NL-OMON43446
Withdrawn
Not Applicable
A Phase 1 Pharmacokinetic-Pharmacodynamic Study of Avelumab (MSB00100718C) in Patients with Previously Treated Advanced Stage Classical Hodgkin*s Lymphoma - Javelin Hodgkin's
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hodgkin's Lymphoma
- Sponsor
- Pfizer
- Enrollment
- 15
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histological confirmation of classical Hodgkin's Lymphoma (cHL) with relapsed or refractory disease, who either have had prior autologous or allogenic stem cell transplantation (SCT) or are not eligible for SCT.
- •2\. Patients must be off previous cHL therapy for at least 28 days prior to
- •randomization.
- •3\. At least 1 FDG\-PET\-avid (Deauville 4/5\) measurable lesion \>1\.5 cm as defined by Response Criteria for Malignant Lymphoma that has not previously been irradiated.
- •4\. Age \*18 years.
- •5\. Estimated life expectancy of at least 3 months.
- •6\. ECOG Performance Status (PS) 0 or 1\.
- •7\. Adequate bone marrow function including:
- •a. Absolute neutrophil count (ANC) \*1,000/mm3 or \*1\.0 x 109/L (may have received G\-CSF support);
- •b. Platelets \*50,000/mm3 or \*50 x 109/L;
Exclusion Criteria
- •1\. Patients with prior allogeneic stem cell transplantation (SCT) who
- •a. allo\-SCT performed \<12 months prior to randomization; or
- •b. immunosuppressive treatment for acute or chronic graft\-versus\-host disease (GVHD) within 3 months prior to randomization (with the exception of those patients who required \* 15 mg/day oral prednisone or equivalent); or
- •c. acute Grade 3 or Grade 4 GVHD at any time in the past (as defined by the modified Seattle Glucksberg Criteria29\); or
- •d. prior chronic GVHD (as defined by the NIH Consensus Development Project30\), persisting for \>6 months, which required systemic immunosuppression (with the exception of those patients who required \* 15 mg/day oral prednisone or equivalent); or
- •e. a donor lymphocyte infusion (DLI) within 6 months prior to randomization.
- •2\. Prior therapy with an anti\-PD\-1 or anti\-PD\-L1\. May be enrolled if patient had stopped prior anti\-PD1 therapy more than one year ago and had responded.
- •3\. Persisting toxicity related to prior therapy NCI CTCAE v4\.0 Grade \>1, except alopecia; also, sensory neuropathy Grade \* 2 is acceptable.
- •4\. Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry.
- •5\. Prior palliative radiotherapy to lesion(s) is permitted as long as there is at least one target lesion evaluable for anti\-tumor activity.
Outcomes
Primary Outcomes
Not specified
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